Countdown to Mandatory European Clinical Trials System

The first few weeks of 2023 will see a frantic race across Europe to finalize the operational details of the new European clinical trials information system. The looming deadline of Jan. 31 has been common knowledge for years now, but it still implies plenty of adjustments by trial sponsors, national authorities, and the European medicines agency (EMA)—which is responsible for the new system.

The system is, of course, designed ultimately as a simplification of the divergent national rules across Europe, but inevitably the intrinsic complexities of clinical trials and the process of clinical trials authorization affecting dozens of countries mean that the implementation of the new system bristles with its own challenges. Over the last year, since the system was launched on a voluntary basis, EMA has worked with sponsors and EU member states to tackle the technical issues that have come up, in a bid to strengthen the system and its portal ahead of compulsory use.

Some 200 clinical trial applications have been authorized under the new system in the last few months, and another 200 are under evaluation, and this experience has helped to identify some of the areas that need improvement. As EMA has acknowledged more than once over the last few months, some users have had problems with the system, and for months it has been a question of all hands on deck to improve the use of experience for the core processes by the time the use of the system becomes mandatory for all new applications. As an illustration of these complexities, the latest December update from EMA included provisions such as new options for the system to register trial sites not registered in a national business registry, or to allow multiple users to work on the same application, or a facility for clearly restricting publication of certain documents.

Despite all the last-minute efforts, anxieties about the readiness of the system—and of the intended users in the clinical trials community—have been reaching fever pitch in some parts of the EU. A coalition of German researchers, ethics committees, and pharmaceutical industry associations registered their disquiet in a joint statement just before the end of 2022.

“The CTIS portal suffers from serious shortcomings even after 10 months of use, and for all those involved it is largely unmanageable,” they said, claiming that the problems had got worse rather than better. Applications for clinical trials and for processing by ethics committees “are massively impaired and cannot be managed,” they warned. The challenge is even wider, they went on: “If this portal does not function properly, the entire system of the EU regulation is in danger of failing,” which could seriously weaken the competitiveness of Europe as a research location, as well as jeopardizing patients.” The already-worrying drift of drug trials beyond Europe could be massively amplified. What they term “the dysfunctional nature of the portal” is so severe a problem that the deadline should be extended, they argued.

The chances of that happening are low. At the urging of the German coalition, the German delegation at the EU health council in late December formally raised the issue—but the council merely took note of the position. Within weeks, the system, perfect or imperfect, will be in operation and the clinical trial community will just have to adapt to it for the time being.